The real “pain point” for providers should be inadequate systems, not quality oversight. I’m referring to Kimberly Marselas’ recent article that portrays the Center for Medicare & Medicaid Services’ ...
In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors. In 1987, when the US Food and Drug ...
Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. FDA issued the guidance document Process Validation: General Principles ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...
May 7, 2024 --Siemens Digital Industries Software today introduced Solido™ IP Validation Suite software, a comprehensive, automated signoff solution for quality assurance across all design ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Pharmasys, a leading life sciences GxP systems consulting ...
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